This study will evaluate whether the addition of Sitagliptin treatment provides a greater decrease in A1C levels compared to placebo in participants with inadequate glycemic control on sulfonylurea and metformin combination therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
427
Phase A (Weeks 0-24): Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): Sitagliptin 100 mg once a day for 30 weeks
Phase B (Weeks 24-54): placebo to pioglitazone 30 mg once a day for 30 weeks
Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): placebo to Sitagliptin once a day for 30 weeks
Change From Baseline in Hemoglobin A1C (%) at Week 24
Change from baseline reflects the Week 24 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.
Time frame: Baseline and Week 24
Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54
Time frame: Week 0 to Week 54
Number of Participants Discontinuing Study Drug Due to An Adverse Event
Time frame: Week 0 to Week 54
Change From Baseline in 2-hour Post-Meal Glucose at Week 24
Change from baseline reflects the Week 24 value minus the baseline value. Two-hour post-meal glucose was measured following a standard meal.
Time frame: Baseline and Week 24
Change From Baseline in Fasting Plasma Glucose at Week 24
Change from baseline reflects the Week 24 value minus the baseline value.
Time frame: Baseline to Week 24
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Phase B (Weeks 24-54): pioglitazone 30 mg once a day for 30 weeks
Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of glimepiride or gliclazide; Phase B (Weeks 24-54): stable dose, as prescribed by investigator, of glimepiride or gliclazide
Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of metformin; Phase B (Weeks 24- 54): stable dose, as prescribed by investigator, of metformin
Phase A (Weeks 0-24): participants not meeting specific glycemic goals will receive pioglitazone (open label) at a dose determined by the investigator. These participants will not initiate Phase B (Weeks 24-54) double blind pioglitazone.